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Customs Proposes To Substantially Transform The Substantial Transformation Test

Client Alert | less than 1 min read | 08.08.08

By Notice of Proposed Rulemaking, 73 Fed. Reg. 43385 (July 25, 2008), Customs & Border Enforcement has proposed substituting, for many purposes including rulings under the Trade Agreements Act (TAA), a "tariff shift" approach for determining country of origin in lieu of the longstanding and subjective "case-by-case" approach to determining the place where "substantial transformation" occurred. Under the proposed rule, contractors selling products under the contracts subject to the TAA would have to reevaluate their products under the rigid, pre-established formulaic tariff shift analysis to ensure products with significant non-designated country content qualify for sale to the federal government.

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Client Alert | 4 min read | 01.07.26

FDA Request for Information Signals New Path for VC Firms and their Portfolio Companies in Federal Contracting

On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026....